search
Back to results

Alcohol Intervention for First Year College Students

Primary Purpose

Underage Alcohol Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Messaging Intervention
Active Control
Sponsored by
University of North Texas Health Science Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Underage Alcohol Use

Eligibility Criteria

18 Years - 19 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Eligibility criteria includes:

  • age 18-19 (see Identity and Age Verification below; If a participant screens in at 18 and turns 20 prior to the focus group, the participant will be allowed to be in the research study.)
  • birth date that is consistent with their given age
  • first-year college student at the University of North Texas
  • valid email address
  • have a text messaging plan on their mobile phone
  • drinking 14/7 or fewer drinks per week for men/women
  • no episodes in the past month of consuming 5/4 drinks in two hours for men/women
  • express any willingness to take a sip of alcohol
  • if female, must not be pregnant or trying to get pregnant
  • willing to participate in focus groups at the University of North Texas

Exclusion Criteria:

  • Not meeting inclusion criteria
  • unwillingness to participate
  • failure to provide consent (e.g., declining participation in the study)
  • providing inconsistent responses (e.g., age) identified by the survey
  • having already participated in the study as identified by overlap or consistency in computer IP addresses, contact information, and demographics

Sites / Locations

  • Dana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Text Messaging Intervention Group

Active Control

Arm Description

Participants in the TM Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful.

Participants in the attention only control condition will receive a series of TM based on nutritional data on the same schedule as those in the TM intervention and will complete a 6 week post-intervention assessment as well as all follow-ups.

Outcomes

Primary Outcome Measures

Acceptability-favorable
proportion of participants who found the study favorable
Acceptability-recommend
proportion of participants who would recommend the study
Acceptability-TMs
ratings of TM content areas from 0-4 with higher numbers being more acceptable
Feasibility- recruitment
number of eligible participants
Feasibility-6 week retention
study retention (% who completed 6 week survey)
Feasibility-3 month retention
study retention (% who completed 3 month survey)
Feasibility-6 month retention
study retention (% who completed 6 month survey)
Feasibility- 9 month retention
study retention (% who completed 9 month survey)

Secondary Outcome Measures

Alcohol Initiation
Initiated drinking (yes or no) since last assessment
Alcohol initiation
Initiated drinking (yes or no) since last assessment
Alcohol initiation
Initiated drinking (yes or no) since last assessment
Alcohol onitiation
Initiated drinking (yes or no) since last assessment
Alcohol escalation
number of drinks
Alcohol escalation
number of drinks
Alcohol escalation
number of drinks
Alcohol escalation
number of drinks

Full Information

First Posted
November 20, 2018
Last Updated
August 28, 2023
Sponsor
University of North Texas Health Science Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT03750838
Brief Title
Alcohol Intervention for First Year College Students
Official Title
Refining and Piloting a Text Messaging Intervention to Delay Alcohol Initiation and Reduce Alcohol Use Escalation Among Abstainer and Lighter Drinker College Students
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Texas Health Science Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
While a large focus of research on U.S. college drinking has focused on the prevalence of and problems related to heavy-episodic drinking, less has focused on college students who are either abstainers or lighter drinkers (i.e., for men, drinking 4 or fewer drinks in two hours and 14 or fewer drinks per week; and for women drinking 3 or fewer in two hours and 7 or fewer drinks per week). Over 40% percent of college students ages 18-22 do not report drinking in the past month with only half of those engaging in regular heavy-episodic drinking. Research suggests that a significant proportion of students who were abstinent or light drinkers prior to and upon entering college initiate drinking and progress to becoming heavy-episodic drinkers. This provides evidence that the first few months of college is a high-risk time for initiating both drinking and heavy-episodic drinking and that delaying the onset of heavy-episodic drinking among light drinkers and abstainers should lead to reduced harms throughout the college years and young adulthood. Mobile phone-based interventions are an innovative method for reaching young people and have been established as an empirical approach towards addressing health issues, including alcohol use. The ultimate goal of this proposal is to develop, refine and pilot a text message (TM) intervention for abstainer and lighter drinking first year college students with the ultimate goal of delaying alcohol initiation and/or reducing alcohol use escalation. An iterative process of focus groups, intervention content development, and user feedback focused on the unique experiences of abstainers and lighter drinkers will inform the TM Intervention to be delivered in a pilot study with 6 weeks of TMs. The pilot study will include a 6 week post-intervention assessment, and 3, 6, and 9 month follow-ups among 100 incoming first year abstainer and lighter drinker college students. Given that reducing young adults' and college students' engagement in excessive alcohol use has been listed as a major objective of Healthy People 2020 and a key priority of NIAAA, an intervention that focuses on delaying alcohol initiation and escalation into higher-risk alcohol use among abstainer and lighter drinkers could make important strides to achieving this goal.
Detailed Description
The first year at college, and specifically the first 6 weeks of college, has been identified as a critical period particularly influential to college students' alcohol use trajectories. The prevalence of heavy drinking increases rapidly upon college entry relative to pre-college use and patterns of high-risk alcohol use established during the transition to college can result in a range of adverse consequences that persist throughout the academic year. While a large focus of research on U.S. college drinking has been on the prevalence of and problems related to heavy-episodic drinking (4+/5+ drinks in two hours for women/men), less research has focused on college students who are either abstainers (i.e., do not drink any alcohol) or lighter drinkers (i.e., men: 4 or fewer drinks in two hours and 14 or fewer drinks per week; women: 3 or fewer in two hours and 7 or fewer drinks per week). Research indicates that between 21% and 26% of first-year colleges students who were abstinent or light drinkers before college escalated to heavy episodic drinking during their freshman year. Further, over 40% percent of college students ages 18-22 do not report drinking in the past month, with only half of those engaging in regular heavy-episodic drinking. Research indicates that risk cognitions (i.e., prototypes, norms) are associated with initiation and escalation of alcohol use and also tend to peak around the time that individuals transition out of high school and into a riskier college environment. Delaying the onset of heavy-episodic drinking among abstainers and lighter drinkers during the first-year of college, a particularly high-risk period, should lead to reduced related harms throughout both the college years and young adulthood. Tailoring intervention approaches to students at various levels of risk, including abstainers or lighter drinkers, may greatly increase efficacy and reduce costs associated with universal interventions (King et al., 2008). No single intervention is likely to sufficiently reduce college drinking or consequences; therefore a "mix of strategies is best". An underexplored strategy is delivering intervention content that reinforces existing reasons for not drinking among abstainers and lighter drinkers, with the goal of delaying the initiation of heavy drinking and/or the escalation to heavy drinking during the first year of college. Given that longitudinal findings indicate that stronger endorsement of reasons for drinking lightly or not drinking, such as academic responsibilities, normative influence, and concern for social images are associated with delayed alcohol initiation, lower levels of alcohol use and higher rates of abstention among young adults, including college students, interventions for abstainers and lighter drinkers that focus on reinforcing proximal reasons not to drink or to drink lightly have promise to dissuade students from initiation of drinking or to delay more hazardous drinking patterns later on. Additionally, mobile phone-based interventions are an innovative method for reaching young people and have been established as an evidence-based, recommended approach towards addressing health issues including alcohol use. Mobile phone text-messaging (TM) offers an innovative technological approach to brief intervention for college students in a mode in which they are familiar and they already use frequently. Presenting preventative intervention content via TM, especially for abstainer and lighter drinking college students, may be one way to delay alcohol use initiation and prevent the escalation of alcohol use during the first year of college. Therefore, the present project has the following primary aims: Aim 1: Recruit first year college students who are abstainers and lighter drinkers to examine students' reactions to TM intervention content through an iterative process of focus groups, intervention content development, and user feedback, which will inform a new intervention to be delivered in a pilot study (Aim 3). Aim 2: Through focus groups, elicit responses to timing of the TM intervention, specifically what days and times per week and how many times per day (set within research-established ranges) abstainer and lighter drinkers think receiving TMs will the most useful and impactful to inform TM delivery for the pilot study (Aim 3). Aim 3: Conduct a pilot study with 6 weeks of TM intervention content, a 6 week post-intervention assessment and 3, 6, and 9 month follow-ups among 100 abstainer or lighter drinking first-year college students to determine feasibility, acceptability, and preliminary effect sizes (to estimate power and sample sizes for a future R01). Newly enrolled first-year college students will be randomized to the TM intervention or attention only control. The investigators hypothesize the TM Intervention will be feasible and acceptable to abstainer and lighter drinking students, including being accessible, usable, convenient, relevant and helpful. The investigators further hypothesize that receiving the TM intervention will be associated with less initiation and escalation of drinking, fewer negative consequences, more favorable prototypes of abstainers and lighter drinkers, greater perceived abstaining and light drinking norms, greater engagement and enjoyment of alternative activities, and greater endorsement of personal goals that do not involve alcohol at the 6 week post-intervention assessment and 3, 6, and 9 month follow-ups relative to attention only control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Underage Alcohol Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text Messaging Intervention Group
Arm Type
Experimental
Arm Description
Participants in the TM Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful.
Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
Participants in the attention only control condition will receive a series of TM based on nutritional data on the same schedule as those in the TM intervention and will complete a 6 week post-intervention assessment as well as all follow-ups.
Intervention Type
Behavioral
Intervention Name(s)
Text Messaging Intervention
Intervention Description
The content for the TM Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.
Intervention Type
Behavioral
Intervention Name(s)
Active Control
Intervention Description
Participants will receive a series of TM based on nutritional data on the same schedule as those in the TM intervention and will complete a 6 week post-intervention assessment as well as all follow-ups.
Primary Outcome Measure Information:
Title
Acceptability-favorable
Description
proportion of participants who found the study favorable
Time Frame
6 weeks
Title
Acceptability-recommend
Description
proportion of participants who would recommend the study
Time Frame
6 weeks
Title
Acceptability-TMs
Description
ratings of TM content areas from 0-4 with higher numbers being more acceptable
Time Frame
6 weeks
Title
Feasibility- recruitment
Description
number of eligible participants
Time Frame
screening
Title
Feasibility-6 week retention
Description
study retention (% who completed 6 week survey)
Time Frame
6 weeks
Title
Feasibility-3 month retention
Description
study retention (% who completed 3 month survey)
Time Frame
3 months
Title
Feasibility-6 month retention
Description
study retention (% who completed 6 month survey)
Time Frame
6 months
Title
Feasibility- 9 month retention
Description
study retention (% who completed 9 month survey)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Alcohol Initiation
Description
Initiated drinking (yes or no) since last assessment
Time Frame
6 weeks
Title
Alcohol initiation
Description
Initiated drinking (yes or no) since last assessment
Time Frame
3 months
Title
Alcohol initiation
Description
Initiated drinking (yes or no) since last assessment
Time Frame
6 months
Title
Alcohol onitiation
Description
Initiated drinking (yes or no) since last assessment
Time Frame
9 months
Title
Alcohol escalation
Description
number of drinks
Time Frame
6 weeks
Title
Alcohol escalation
Description
number of drinks
Time Frame
3 months
Title
Alcohol escalation
Description
number of drinks
Time Frame
6 months
Title
Alcohol escalation
Description
number of drinks
Time Frame
9 months

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Eligibility criteria includes: age 18-19 (see Identity and Age Verification below; If a participant screens in at 18 and turns 20 prior to the focus group, the participant will be allowed to be in the research study.) birth date that is consistent with their given age first-year college student at the University of North Texas valid email address have a text messaging plan on their mobile phone drinking 14/7 or fewer drinks per week for men/women no episodes in the past month of consuming 5/4 drinks in two hours for men/women express any willingness to take a sip of alcohol if female, must not be pregnant or trying to get pregnant willing to participate in focus groups at the University of North Texas Exclusion Criteria: Not meeting inclusion criteria unwillingness to participate failure to provide consent (e.g., declining participation in the study) providing inconsistent responses (e.g., age) identified by the survey having already participated in the study as identified by overlap or consistency in computer IP addresses, contact information, and demographics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana M Litt, PhD.
Organizational Affiliation
University of North Texas Health Science Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
A select number of researchers will have access to unidentified participant data at the close of the study.

Learn more about this trial

Alcohol Intervention for First Year College Students

We'll reach out to this number within 24 hrs